Akebia Therapeutics, Inc.

Good day and thank you for standing by. Welcome to Akebia's third quarter 2025 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.

Thank you, and welcome to Kibia's third quarter 2025 financial results and business updates conference call. Please note that a press release was issued earlier today, Monday, November 10th, detailing our third quarter 2025 financial results, and that release is available on the Investors section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, Nick Grund, Chief Commercial Officer, and Eric Ostrowski, Chief Financial and Chief Business Officer. I'd like to remind everyone that this call includes forward-looking statements, Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on November 10th, as well as in our risk factors and management discussion and analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes, and thanks to all of you for joining us this morning. The team is just back from a very successful American Society of Nephrology meeting where we met with prescribers and customers and also presented data that continue to demonstrate the positive impact VASIO can potentially have on important clinical outcomes in dialysis patients. The quality of data that we believe will lead to VASIO becoming standard of care to treat anemia in dialysis patients. Of course, today there is significant focus on our current launch progress. I'm proud to share that through 41 weeks of launch, Vafsio has generated more total prescriptions than any recent launch in dialysis. This is a reflection of the recognition from prescribers of the potential clinical benefit Vafsio can bring. That being said, from a business perspective, I'm not satisfied with generating $14.3 million in revenue this quarter. No one on the Akebia team is. But to be clear, we are pleased with the direction of all the important launch indicators that we believe will lead to long-term success for the product. We increased accessible patients from 40,000 patients in the first half of the year to almost 70,000 by the end of Q3, with the initiation of the DaVita pilot and the addition of IRC and several smaller providers late in the quarter. However, as we advance through the launch, we continue to appreciate how long it takes to align all of the logistics and processes for a new therapy to be made available for patients, particularly one that will be delivered to a patient's home, a departure from how anemia has been treated for the past 35 years. The bottom line is that getting patients on therapy, and in some cases, keeping them on, in the highly protocolized dialysis environment has taken longer than we expected. That said, these are operational issues that we and our dialysis provider customers are working through as quickly as possible. We believe that our positioning is compelling. Market research and every conversation I had at the ASN meeting supports physician desire to prescribe. Nick will share more information on our launch as well as sentiments from prescribers that we heard at ASN. Further, I expect that strong interest from physicians is only going to grow with the win-odds analysis based on data from the INOVAIT trials that was presented at ASN last week by Dr. Glenn Chertow. The purpose of the win-odds analysis is to bring a greater level of statistical power to analyzing critical clinical outcomes. It's a statistical method designed to prioritize clinically meaningful endpoints in outcomes trials. This post hoc data analysis showed that patients randomized to batadustat experienced a lower risk of death or hospitalization compared with patients randomized to the ESA control, darbopoietin alpha. The benefit became more significant when you looked at an on-treatment analysis. You've heard me say repeatedly that continuing to provide data that supports the clinical differentiation of VASIO will be critical for the product to become standard of care. This data is an incredibly strong start and an important step in delivering on that promise. We will, of course, work diligently to have these new data published so our medical team can communicate them in the field as appropriate. Moreover, Dr. Block has adopted this win-odds endpoint as the primary endpoint in the voice study, which we expect to read out in early 2027. As a reminder, late next year, we'll also have the results from the vocal study that we're conducting at DaVita Clinics. These readouts will be two important data catalysts for the company, and we believe the newly generated information should support continued long-term growth of Vafsio prescribing. Now, both the voice and vocal studies utilize three times weekly, or TIW, dosing regimens. We've said before that observed dosing will be important for the in-center patient population as the dosing schedule can coincide with their dialysis treatments. Now, we plan to engage further with the FDA on adding TIW dosing to the label, but we have heard from physicians and providers that they are moving to this dosing regimen based on the evidence that already exists. To this end, U.S. Renal Care is currently implementing a TIW dosing protocol in their clinics with a goal to have it available in all clinics in Q1 of next year. I expect some physicians may wait until Q1 to start new patients on Vafsio when they can leverage TIW dosing. Now, additionally, USRC will be shifting from using 150 milligram tablets at home to 300 milligram tablets for in-center use, which could impact inventory levels in Q4. In the long run, I believe this change, enabling observed dosing, will improve physicians' ability to drive patient adherence and compliance which have been factors impacting growth. Before handing the call over to Nick, I want to go back to our launch for a moment. Having more prescriptions written in the first 41 weeks of a launch than any recent launch in dialysis suggests a very strong reception from the dialysis community. Hearing feedback from physicians about their positive experiences with Vafsio And seeing data like Dr. Chertow presented regarding the potential favorable mortality and decreased hospitalization benefits compared to ESAs gives me more reason to believe we will achieve our goal of making VAPCO standard of care for dialysis patients. I'm extremely confident in achieving that long-term goal. In the near term, our team is tackling operational issues head-on to overcome them. Now, let me turn it over to Nick to give more granularity on these efforts.